Exercise therapy for chronic low back pain Hayden, Jill A; Ellis, Jenna; Ogilvie, Rachel ...
Cochrane database of systematic reviews,
09/2021, Letnik:
9
Journal Article
Recenzirano
Odprti dostop
Low back pain has been the leading cause of disability globally for at least the past three decades and results in enormous direct healthcare and lost productivity costs.
The primary objective of ...this systematic review is to assess the impact of exercise treatment on pain and functional limitations in adults with chronic non-specific low back pain compared to no treatment, usual care, placebo and other conservative treatments.
We searched CENTRAL (which includes the Cochrane Back and Neck trials register), MEDLINE, Embase, CINAHL, PsycINFO, PEDro, SPORTDiscus, and trials registries (ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform), and conducted citation searching of relevant systematic reviews to identify additional studies. The review includes data for trials identified in searches up to 27 April 2018. All eligible trials have been identified through searches to 7 December 2020, but have not yet been extracted; these trials will be integrated in the next update.
We included randomised controlled trials that assessed exercise treatment compared to no treatment, usual care, placebo or other conservative treatment on the outcomes of pain or functional limitations for a population of adult participants with chronic non-specific low back pain of more than 12 weeks' duration.
Two authors screened and assessed studies independently, with consensus. We extracted outcome data using electronic databases; pain and functional limitations outcomes were re-scaled to 0 to 100 points for meta-analyses where 0 is no pain or functional limitations. We assessed risk of bias using the Cochrane risk of bias (RoB) tool and used GRADE to evaluate the overall certainty of the evidence. When required, we contacted study authors to obtain missing data. To interpret meta-analysis results, we considered a 15-point difference in pain and a 10-point difference in functional limitations outcomes to be clinically important for the primary comparison of exercise versus no treatment, usual care or placebo.
We included 249 trials of exercise treatment, including studies conducted in Europe (122 studies), Asia (38 studies), North America (33 studies), and the Middle East (24 studies). Sixty-one per cent of studies (151 trials) examined the effectiveness of two or more different types of exercise treatment, and 57% (142 trials) compared exercise treatment to a non-exercise comparison treatment. Study participants had a mean age of 43.7 years and, on average, 59% of study populations were female. Most of the trials were judged to be at risk of bias, including 79% at risk of performance bias due to difficulty blinding exercise treatments. We found moderate-certainty evidence that exercise treatment is more effective for treatment of chronic low back pain compared to no treatment, usual care or placebo comparisons for pain outcomes at earliest follow-up (MD -15.2, 95% CI -18.3 to -12.2), a clinically important difference. Certainty of evidence was downgraded mainly due to heterogeneity. For the same comparison, there was moderate-certainty evidence for functional limitations outcomes (MD -6.8 (95% CI -8.3 to -5.3); this finding did not meet our prespecified threshold for minimal clinically important difference. Certainty of evidence was downgraded mainly due to some evidence of publication bias. Compared to all other investigated conservative treatments, exercise treatment was found to have improved pain (MD -9.1, 95% CI -12.6 to -5.6) and functional limitations outcomes (MD -4.1, 95% CI -6.0 to -2.2). These effects did not meet our prespecified threshold for clinically important difference. Subgroup analysis of pain outcomes suggested that exercise treatment is probably more effective than education alone (MD -12.2, 95% CI -19.4 to -5.0) or non-exercise physical therapy (MD -10.4, 95% CI -15.2 to -5.6), but with no differences observed for manual therapy (MD 1.0, 95% CI -3.1 to 5.1). In studies that reported adverse effects (86 studies), one or more adverse effects were reported in 37 of 112 exercise groups (33%) and 12 of 42 comparison groups (29%). Twelve included studies reported measuring adverse effects in a systematic way, with a median of 0.14 (IQR 0.01 to 0.57) per participant in the exercise groups (mostly minor harms, e.g. muscle soreness), and 0.12 (IQR 0.02 to 0.32) in comparison groups.
We found moderate-certainty evidence that exercise is probably effective for treatment of chronic low back pain compared to no treatment, usual care or placebo for pain. The observed treatment effect for the exercise compared to no treatment, usual care or placebo comparisons is small for functional limitations, not meeting our threshold for minimal clinically important difference. We also found exercise to have improved pain (low-certainty evidence) and functional limitations outcomes (moderate-certainty evidence) compared to other conservative treatments; however, these effects were small and not clinically important when considering all comparisons together. Subgroup analysis suggested that exercise treatment is probably more effective than advice or education alone, or electrotherapy, but with no differences observed for manual therapy treatments.
Low back pain (LBP) is a common and disabling disorder in western society. The management of LBP comprises a range of different intervention strategies including surgery, drug therapy, and ...non-medical interventions. The objective of the present study is to determine the effectiveness of physical and rehabilitation interventions (i.e. exercise therapy, back school, transcutaneous electrical nerve stimulation (TENS), low level laser therapy, education, massage, behavioural treatment, traction, multidisciplinary treatment, lumbar supports, and heat/cold therapy) for chronic LBP. The primary search was conducted in MEDLINE, EMBASE, CINAHL, CENTRAL, and PEDro up to 22 December 2008. Existing Cochrane reviews for the individual interventions were screened for studies fulfilling the inclusion criteria. The search strategy outlined by the Cochrane Back Review Groups (CBRG) was followed. The following were included for selection criteria: (1) randomized controlled trials, (2) adult (≥18 years) population with chronic (≥12 weeks) non-specific LBP, and (3) evaluation of at least one of the main clinically relevant outcome measures (pain, functional status, perceived recovery, or return to work). Two reviewers independently selected studies and extracted data on study characteristics, risk of bias, and outcomes at short, intermediate, and long-term follow-up. The GRADE approach was used to determine the quality of evidence. In total 83 randomized controlled trials met the inclusion criteria: exercise therapy (
n
= 37), back school (
n
= 5), TENS (
n
= 6), low level laser therapy (
n
= 3), behavioural treatment (
n
= 21), patient education (
n
= 1), traction (
n
= 1), and multidisciplinary treatment (
n
= 6). Compared to usual care, exercise therapy improved post-treatment pain intensity and disability, and long-term function. Behavioural treatment was found to be effective in reducing pain intensity at short-term follow-up compared to no treatment/waiting list controls. Finally, multidisciplinary treatment was found to reduce pain intensity and disability at short-term follow-up compared to no treatment/waiting list controls. Overall, the level of evidence was low. Evidence from randomized controlled trials demonstrates that there is low quality evidence for the effectiveness of exercise therapy compared to usual care, there is low evidence for the effectiveness of behavioural therapy compared to no treatment and there is moderate evidence for the effectiveness of a multidisciplinary treatment compared to no treatment and other active treatments at reducing pain at short-term in the treatment of chronic low back pain. Based on the heterogeneity of the populations, interventions, and comparison groups, we conclude that there are insufficient data to draw firm conclusion on the clinical effect of back schools, low-level laser therapy, patient education, massage, traction, superficial heat/cold, and lumbar supports for chronic LBP.
Radiofrequency denervation is a commonly used treatment for chronic low back pain, but high-quality evidence for its effectiveness is lacking.
To evaluate the effectiveness of radiofrequency ...denervation added to a standardized exercise program for patients with chronic low back pain.
Three pragmatic multicenter, nonblinded randomized clinical trials on the effectiveness of minimal interventional treatments for participants with chronic low back pain (Mint study) were conducted in 16 multidisciplinary pain clinics in the Netherlands. Eligible participants were included between January 1, 2013, and October 24, 2014, and had chronic low back pain, a positive diagnostic block at the facet joints (facet joint trial, 251 participants), sacroiliac joints (sacroiliac joint trial, 228 participants), or a combination of facet joints, sacroiliac joints, or intervertebral disks (combination trial, 202 participants) and were unresponsive to conservative care.
All participants received a 3-month standardized exercise program and psychological support if needed. Participants in the intervention group received radiofrequency denervation as well. This is usually a 1-time procedure, but the maximum number of treatments in the trial was 3.
The primary outcome was pain intensity (numeric rating scale, 0-10; whereby 0 indicated no pain and 10 indicated worst pain imaginable) measured 3 months after the intervention. The prespecified minimal clinically important difference was defined as 2 points or more. Final follow-up was at 12 months, ending October 2015.
Among 681 participants who were randomized (mean age, 52.2 years; 421 women 61.8%, mean baseline pain intensity, 7.1), 599 (88%) completed the 3-month follow-up, and 521 (77%) completed the 12-month follow-up. The mean difference in pain intensity between the radiofrequency denervation and control groups at 3 months was -0.18 (95% CI, -0.76 to 0.40) in the facet joint trial; -0.71 (95% CI, -1.35 to -0.06) in the sacroiliac joint trial; and -0.99 (95% CI, -1.73 to -0.25) in the combination trial.
In 3 randomized clinical trials of participants with chronic low back pain originating in the facet joints, sacroiliac joints, or a combination of facet joints, sacroiliac joints, or intervertebral disks, radiofrequency denervation combined with a standardized exercise program resulted in either no improvement or no clinically important improvement in chronic low back pain compared with a standardized exercise program alone. The findings do not support the use of radiofrequency denervation to treat chronic low back pain from these sources.
trialregister.nl Identifier: NTR3531.
Low back pain (LBP) is responsible for considerable personal suffering worldwide. Those with persistent disabling symptoms also contribute to substantial costs to society via healthcare expenditure ...and reduced work productivity. While there are many treatment options, none are universally endorsed. The idea that chronic LBP is a condition best understood with reference to an interaction of physical, psychological and social influences, the 'biopsychosocial model', has received increasing acceptance. This has led to the development of multidisciplinary biopsychosocial rehabilitation (MBR) programs that target factors from the different domains, administered by healthcare professionals from different backgrounds.
To review the evidence on the effectiveness of MBR for patients with chronic LBP. The focus was on comparisons with usual care and with physical treatments measuring outcomes of pain, disability and work status, particularly in the long term.
We searched the CENTRAL, MEDLINE, EMBASE, PsycINFO and CINAHL databases in January and March 2014 together with carrying out handsearches of the reference lists of included and related studies, forward citation tracking of included studies and screening of studies excluded in the previous version of this review.
All studies identified in the searches were screened independently by two review authors; disagreements regarding inclusion were resolved by consensus. The inclusion criteria were published randomised controlled trials (RCTs) that included adults with non-specific LBP of longer than 12 weeks duration; the index intervention targeted at least two of physical, psychological and social or work-related factors; and the index intervention was delivered by clinicians from at least two different professional backgrounds.
Two review authors extracted and checked information to describe the included studies, assessed risk of bias and performed the analyses. We used the Cochrane risk of bias tool to describe the methodological quality. The primary outcomes were pain, disability and work status, divided into the short, medium and long term. Secondary outcomes were psychological functioning (for example depression, anxiety, catastrophising), healthcare service utilisation, quality of life and adverse events. We categorised the control interventions as usual care, physical treatment, surgery, or wait list for surgery in separate meta-analyses. The first two comparisons formed our primary focus. We performed meta-analyses using random-effects models and assessed the quality of evidence using the GRADE method. We performed sensitivity analyses to assess the influence of the methodological quality, and subgroup analyses to investigate the influence of baseline symptom severity and intervention intensity.
From 6168 studies identified in the searches, 41 RCTs with a total of 6858 participants were included. Methodological quality ratings ranged from 1 to 9 out 12, and 13 of the 41 included studies were assessed as low risk of bias. Pooled estimates from 16 RCTs provided moderate to low quality evidence that MBR is more effective than usual care in reducing pain and disability, with standardised mean differences (SMDs) in the long term of 0.21 (95% CI 0.04 to 0.37) and 0.23 (95% CI 0.06 to 0.4) respectively. The range across all time points equated to approximately 0.5 to 1.4 units on a 0 to 10 numerical rating scale for pain and 1.4 to 2.5 points on the Roland Morris disability scale (0 to 24). There was moderate to low quality evidence of no difference on work outcomes (odds ratio (OR) at long term 1.04, 95% CI 0.73 to 1.47). Pooled estimates from 19 RCTs provided moderate to low quality evidence that MBR was more effective than physical treatment for pain and disability with SMDs in the long term of 0.51 (95% CI -0.01 to 1.04) and 0.68 (95% CI 0.16 to 1.19) respectively. Across all time points this translated to approximately 0.6 to 1.2 units on the pain scale and 1.2 to 4.0 points on the Roland Morris scale. There was moderate to low quality evidence of an effect on work outcomes (OR at long term 1.87, 95% CI 1.39 to 2.53). There was insufficient evidence to assess whether MBR interventions were associated with more adverse events than usual care or physical interventions.Sensitivity analyses did not suggest that the pooled estimates were unduly influenced by the results from low quality studies. Subgroup analyses were inconclusive regarding the influence of baseline symptom severity and intervention intensity.
Patients with chronic LBP receiving MBR are likely to experience less pain and disability than those receiving usual care or a physical treatment. MBR also has a positive influence on work status compared to physical treatment. Effects are of a modest magnitude and should be balanced against the time and resource requirements of MBR programs. More intensive interventions were not responsible for effects that were substantially different to those of less intensive interventions. While we were not able to determine if symptom intensity at presentation influenced the likelihood of success, it seems appropriate that only those people with indicators of significant psychosocial impact are referred to MBR.
Purpose
Inconsistent reporting of outcomes in clinical trials of patients with non-specific low back pain (NSLBP) hinders comparison of findings and the reliability of systematic reviews. A core ...outcome set (COS) can address this issue as it defines a minimum set of outcomes that should be reported in all clinical trials. In 1998, Deyo et al. recommended a standardized set of outcomes for LBP clinical research. The aim of this study was to update these recommendations by determining which outcome domains should be included in a COS for clinical trials in NSLBP.
Methods
An International Steering Committee established the methodology to develop this COS. The OMERACT Filter 2.0 framework was used to draw a list of potential core domains that were presented in a Delphi study. Researchers, care providers and patients were invited to participate in three Delphi rounds and were asked to judge which domains were core. A priori criteria for consensus were established before each round and were analysed together with arguments provided by panellists on importance, overlap, aggregation and/or addition of potential core domains. The Steering Committee discussed the final results and made final decisions.
Results
A set of 280 experts was invited to participate in the Delphi; response rates in the three rounds were 52, 50 and 45 %. Of 41 potential core domains presented in the first round, 13 had sufficient support to be presented for rating in the third round. Overall consensus was reached for the inclusion of three domains in this COS: ‘physical functioning’, ‘pain intensity’ and ‘health-related quality of life’. Consensus on ‘physical functioning’ and ‘pain intensity’ was consistent across all stakeholders, ‘health-related quality of life’ was not supported by the patients, and all the other domains were not supported by two or more groups of stakeholders. Weighting all possible argumentations, the Steering Committee decided to include in the COS the three domains that reached overall consensus and the domain ‘number of deaths’.
Conclusions
The following outcome domains were included in this updated COS: ‘physical functioning’, ‘pain intensity’, ‘health-related quality of life’ and ‘number of deaths’. The next step for the development of this COS will be to determine which measurement instruments best measure these domains.
To standardize outcome reporting in clinical trials of patients with nonspecific low back pain, an international multidisciplinary panel recommended physical functioning, pain intensity, and ...health-related quality of life (HRQoL) as core outcome domains. Given the lack of a consensus on measurement instruments for these 3 domains in patients with low back pain, this study aimed to generate such consensus. The measurement properties of 17 patient-reported outcome measures for physical functioning, 3 for pain intensity, and 5 for HRQoL were appraised in 3 systematic reviews following the COSMIN methodology. Researchers, clinicians, and patients (n = 207) were invited in a 2-round Delphi survey to generate consensus (≥67% agreement among participants) on which instruments to endorse. Response rates were 44% and 41%, respectively. In round 1, consensus was achieved on the Oswestry Disability Index version 2.1a for physical functioning (78% agreement) and the Numeric Rating Scale (NRS) for pain intensity (75% agreement). No consensus was achieved on any HRQoL instrument, although the Short Form 12 (SF12) approached the consensus threshold (64% agreement). In round 2, a consensus was reached on an NRS version with a 1-week recall period (96% agreement). Various participants requested 1 free-to-use instrument per domain. Considering all issues together, recommendations on core instruments were formulated: Oswestry Disability Index version 2.1a or 24-item Roland-Morris Disability Questionnaire for physical functioning, NRS for pain intensity, and SF12 or 10-item PROMIS Global Health form for HRQoL. Further studies need to fill the evidence gaps on the measurement properties of these and other instruments.
Method guideline for systematic reviews of trials of interventions for neck and back pain, and related spinal disorders.
To help authors design, conduct, and report systematic reviews of trials in ...this field.
In 1997, the Cochrane Back Review Group editorial board published the Method Guideline for Systematic Reviews, which was updated in 2003 and in 2009. Since then, new methodological evidence has emerged and standards have changed, therefore it was clear that revisions were needed to the 2009 guideline. In May 2015 the group changed its name to Cochrane Back and Neck.
The editorial board met in September 2014 to review the relevant new methodological evidence and determine how it should be incorporated. Members of the advisory board were consulted. Based on the feedback received, an updated method guideline was prepared and approved by the editorial board.
We have updated recommendations in 7 categories: objectives, literature search, selection criteria, risk of bias assessment, data extraction, data analysis, and reporting of results and conclusions. Each category is classified into minimum criteria (mandatory) and further guidance (optional). This update also includes some new guidance for preparation of summary of finding tables and for conducting nonintervention reviews.
Citations of previous versions of the method guideline in published scientific articles (1193 in total) suggest that others may find this guideline useful to plan, conduct, or evaluate systematic reviews in the field of back and neck pain, and spinal disorders.
N/A.
Exercise therapy for chronic nonspecific low-back pain van Middelkoop, Marienke, PhD; Rubinstein, Sidney M., PhD; Verhagen, Arianne P., PhD ...
Best practice & research. Clinical rheumatology,
04/2010, Letnik:
24, Številka:
2
Journal Article
Recenzirano
Exercise therapy is the most widely used type of conservative treatment for low back pain. Systematic reviews have shown that exercise therapy is effective for chronic but not for acute low back ...pain. During the past 5 years, many additional trials have been published on chronic low back pain. This articles aims to give an overview on the effectiveness of exercise therapy in patients with low back pain. For this overview, existing Cochrane reviews for the individual interventions were screened for studies fulfilling the inclusion criteria, and the search strategy outlined by the Cochrane Back Review Group (CBRG) was followed. Studies were included if they fulfilled the following criteria: (1) randomised controlled trials,(2) adult (≥18 years) population with chronic (≥12 weeks) nonspecific low back pain and (3) evaluation of at least one of the main clinically relevant outcome measures (pain, functional status, perceived recovery or return to work). Two reviewers independently selected studies and extracted data on study characteristics, risk of bias and outcomes at short-term, intermediate and long-term follow-up. The GRADE approach (GRADE, Grading of Recommendations Assessment, Development and Evaluation) was used to determine the quality of evidence. In total, 37 randomised controlled trials met the inclusion criteria and were included in this overview. Compared to usual care, exercise therapy improved post-treatment pain intensity and disability, and long-term function. The authors conclude that evidence from randomised controlled trials demonstrated that exercise therapy is effective at reducing pain and function in the treatment of chronic low back pain. There is no evidence that one particular type of exercise therapy is clearly more effective than others. However, effects are small and it remains unclear which subgroups of patients benefit most from a specific type of treatment.
Objectives
To evaluate the cost‐effectiveness of the Geriatric Care Model (GCM), an integrated care model for frail older adults based on the Chronic Care Model, with that of usual care.
Design
...Economic evaluation alongside a 24‐month stepped‐wedge cluster‐randomized controlled trial.
Setting
Primary care (35 practices) in two regions in the Netherlands.
Participants
Community‐dwelling older adults who were frail according to their primary care physicians and the Program on Research for Integrating Services for the Maintenance of Autonomy case‐finding tool questionnaire (N = 1,147).
Intervention
The GCM consisted of the following components: a regularly scheduled in‐home comprehensive geriatric assessment by a practice nurse followed by a customized care plan, management and training of practice nurses by a geriatric expert team, and coordination of care through community network meetings and multidisciplinary team consultations of individuals with complex care needs.
Measurements
Outcomes were measured every 6 months and included costs from a societal perspective, health‐related quality of life (Medical Outcomes Study 12‐item Short‐Form Survey (SF‐12) physical (PCS) and mental component summary (MCS) scales), functional limitations (Katz activities of daily living and instrumental activities of daily living), and quality‐adjusted life years based on the EQ‐5D.
Results
Multilevel regression models adjusted for time and baseline confounders showed no significant differences in costs ($356, 95% confidence interval = −$488–1,134) and outcomes between intervention and usual care phases. Cost‐effectiveness acceptability curves showed that, for the SF‐12 PCS and MCS, the probability of the intervention being cost‐effective was 0.76 if decision‐makers are willing to pay $30,000 per point improvement on the SF‐12 scales (range 0–100). For all other outcomes the probability of the intervention being cost‐effective was low.
Conclusion
Because the GCM was not cost‐effective compared to usual care after 24 months of follow‐up, widespread implementation in its current form is not recommended.
Cost of illness study.
To investigate the total costs of back pain in The Netherlands over the years 2002 to 2007.
In 1991, the cost of back pain to the Dutch society was estimated at € 4.2 billion. ...In the last two decades, new laws regarding health insurance and sickness benefits and new guidelines for health care professionals have been introduced and may have affected the societal costs of back pain in The Netherlands.
We conducted a cost-of-illness study in which we gathered relevant available data from national registries, reports of research institutes, descriptive studies, and occupational health care authorities to estimate the total cost of back pain to the Dutch society for the years 2002 to 2007. RESULTS.: The total costs of back pain decreased from € 4.3 billion in 2002 to € 3.5 billion in 2007. The share of these costs was about 0.9% of the gross national product (GNP) in 2002 and 0.6% of GNP in 2007. The ratio between direct and indirect costs did not change noticeably over the years, that is, 12% for direct and 88% for indirect costs.
The total societal costs of back pain have decreased since 1991 and also between 2002 and 2007. Although Dutch policy interventions to lower the indirect costs seem to be successful in the last decades, costs of back pain are still substantial, and indirect costs represent the majority of these costs. Policy interventions and implementation of cost-effective interventions focusing on return-to-work management for back pain in health care is important to further decrease the economic burden of back pain on society.
PDF
